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Tags: Coronavirus | Coronavirus Special | Health Topics | Vaccines | Cold/Flu | challenge | trials

Are Challenge Trials Answer to Stopping Coronavirus?

a medical doctor purveys the coronavirus data from johns hopkins university
(Evgeniy Parilov/Dreamstime)

By    |   Monday, 27 April 2020 03:04 PM

It is time to expedite development of a vaccine for the devastating  COVID-19, even if it means increased death of volunteers willing to be guinea pigs, some experts say.

In fast-track human challenge trials, volunteers would test the vaccines without the normal long waiting period normally required by the U.S. Food and Drug Administration, says Vox.

Conventional vaccine trials can take years because researchers have to recruit thousands of patients and then wait for them to get infected by the virus naturally. But in a challenge trial, healthy adult volunteers are divided into two groups. One group gets a placebo, while the other receives the potential vaccine. They both are then injected with the virus to see if the vaccine offers some level of protection, according to ABC News.

"If all you care about are outcomes, then challenge studies look like a shorter and easier way to get to the same outcome," noted Dr. Alex John London, a professor of ethics and philosophy and the director of the Center for Ethics and Policy at Carnegie Mellon University.

But some feel challenge trials are unethical because giving the virus to volunteers could result in severe consequences.

"We need to think through this approach, trial, and implications with guidance before we move quickly and have unintended consequences from challenge trials," said Dr. Jay Bhatt, former medical chief at the American Hospital Association and an ABC News contributor. "This trial can lead to individuals having severe infections, complications, and even death. Young, healthy individuals may be at lower risk, but it isn't zero."

Those in favor of conducting challenge trials to beat the coronavirus point out doctors, nurses, and other front-line defenders including police and the military routinely put their lives at risk for the betterment of society. The website 1Day Sooner is already recruiting volunteers for a human challenge trial who are willing to take that risk, too.

Dr. Jennifer Miller, Ph.D., an assistant professor at Yale School of Medicine and founder of Bioethics International and the Good Pharma Scorecard, told ABC News:

"A scientifically rigorous and responsibly designed trial could have high social value—notwithstanding the risks to participants should be minimized."

Miller added, volunteers should include only those less likely to die of infection and who are already in areas with high risk of contracting the infection anyway.

"This is critical," she told ABC News.

© 2021 NewsmaxHealth. All rights reserved.

It is time to expedite development of a vaccine for the devastating COVID-19, even if it means increased death of volunteers willing to be guinea pigs, some experts say.
challenge, trials, testing, pandemic, covid-19
Monday, 27 April 2020 03:04 PM
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